BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112591 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03054
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH, SION; GUIDE CATH: MACH 1 JL4.0. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE 2.25 X 23 MM XIENCE PRIME STENT WAS IMPLANTED; HOWEVER, THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL. THE 2.5 X 12 MM NC TENKU BALLOON CATHETER WAS ADVANCED FOR FURTHER DILATATION, BUT COULD NOT CROSS TO THE STENT. THERE WAS NO DAMAGE NOTED TO THE STENT DURING THE ATTEMPT TO CROSS. AN ADDITIONAL GUIDE WIRE WAS USED FOR SUPPORT, BUT THE NC TENKU BALLOON STILL COULD NOT CROSS TO THE LESION. A NON-ABBOTT BALLOON CATHETER WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212603 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention